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Activity Number: 658
Type: Contributed
Date/Time: Thursday, August 4, 2016 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #320509 View Presentation
Title: Patient Subgroup Identification in Clinical Trials Where Overall Treatment Response Is Suboptimal
Author(s): Isaac Nuamah* and Youping Huang
Companies: Janssen R&D and Janssen R&D
Keywords: subgroup analysis
Abstract:

The primary goal of a randomized controlled trial is to determine the benefits and risks of a new treatment in a patient population. Using only the average response of patients when evaluating clinical trial data can mask important effects in certain patient subgroups. A subgroup analysis is thus sometimes undertaken to assess treatment effects for a specific patient characteristic or to identify a group in which the treatment works best or may be inappropriate. In subgroup analyses, investigators may examine whether the efficacy of a treatment relative to placebo varies according to certain patients' baseline factors. Such analysis should be preplanned and adequately powered or pooled analyses of several trials may be undertaken. However, this is not always possible. In some studies the overall results may be negative or suboptimal, and the question arises if the treatment works in some patient subgroups or is enhanced in some others. This paper proposes an approach of examining the most similar patient characteristics with the goal of identifying important patient subgroups where treatment response is enhanced.


Authors who are presenting talks have a * after their name.

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